Tony Hagen

September 17, 2021

Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.

September 17, 2021

BCD-021 demonstrated equivalence in a phase 3 study involving Russian and Indian patients with advanced non–small cell lung cancer (NSCLC).

September 16, 2021

MIL60 bevacizumab biosimilar candidate demonstrates equivalence to the originator Avastin in a population of Chinese patients with non–small cell lung cancer (NSCLC) treated in a frontline setting.

September 15, 2021

The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.

September 14, 2021

The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.

September 14, 2021

The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.

September 13, 2021

Companies that gain Drug Controller General of India (DCGI) marketing authorization are likely in for much more extensive trials if they hope to commercialize their biosimilars on the global platform.

September 09, 2021

The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.

September 09, 2021

The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.

September 08, 2021

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.